Caregivers-Patients Support Coping With Advanced-Cancer (CASA) Intervention (CASA)

This pilot aims to prepare the PI to receive hands-on experience in implementation and dissemination and design and lead pilot studies in palliative care. The catchment area communities experience lower cancer health outcomes and are more likely to be diagnosed with advanced cancer when compared to other surrounding areas. The PI's catchment area experiences advanced cancer, and their caregivers are at an increased risk for unmet psychosocial needs; this pre-pilot will allow the PI to focus on this critical gap in equal healthcare. The research goal of this proposal is to refine and pre-pilot an intervention titled Caregivers Patients Support to Cope with Advanced Cancer (CASA), a five-session, 60-minute telehealth series for patient-caregiver dyads. The rationale for this project is that it will lay the groundwork for a Randomized Control Trial (RCT) testing the efficacy of CASA. It will also assess the implementation of an innovative method to deliver the CASA intervention. This study aims to use the collaborative intervention planning framework and ORBIT model to modify and assess the feasibility and preliminary effect of the CASA intervention. The overall impact of this study is to improve access to psychosocial interventions in the proposed catchment area.

Study Overview

• Status: Enrolling by invitation
• Conditions: Advanced Cancer; Patients; Caregivers; Stage IV Cancer; Stage III Cancer
• Intervention / Treatment: Behavioral: Placebo; Behavioral: Caregivers-patients support intervention for advanced cancer (CASA)

Detailed Description

The proposed study will follow a mixed-methods pilot study. The intervention trial will involve conducting an adapted Caregivers-Patients Support intervention to Cope with Advanced-Cancer (CASA) randomized clinical trial framed under the the collaborative intervention planning framework. The team will collect data for primary outcome (Spiritual Well-Being Scale) and secondary outcomes. The secondary outcomes include Hospital Anxiety and Depression Scale (HADS), Beck Hopelessness Scale (BHS), Functional Assessment of Cancer Therapy-General (FACT-G), Family Relationship Index, Holding Back subscale, Zarit Burden Interview (ZBI), and NCCN Distress Thermometer. All measures are available in Spanish and the team has used them in previous studies with Hispanic/Latinx patients and caregivers coping with advanced cancer. Highly innovative analyses exploring feasibility and preliminary effect. Definitions of feasibility will include: (1) ≥60% enrollment among approached participants, (2) ≥70% completion of baseline and T2 surveys; (3) ≥80% of participants in the intervention group agreeing with the item CASA was helpful to me; and (4) ≤20% of respondents in the intervention group agreeing with the item CASA placed a considerable burden on me. Preliminary effects evaluation will include: a linear mixed effect modeling and an intent-to-treat approach to analyze the results. The results of FACIT, FRI, HBS, HADS, BHS, DT, FACT-G, and ZB will be analyzed with a paired t-test, Wilcoxon signed ranks test, and McNemar. Linear mixed effect modeling is statistically appropriate because we will use one independent variable (CASA intervention) with more than two dependent/matched groups (patients-control, caregivers-control, patients-in-treatment, caregivers-in-treatment, patients-caregiver-control, and patients-caregivers-in-treatment). The primary outcome is pre- to post-intervention changes in spirituality (FACIT). Change scores have the advantage of clearly showing the direction of change. The linear mixed effects model analysis will include two primary fixed-effect covariates: 1) spirituality to provide some control over variability in participants baseline; and 2) treatment assignment (CASA vs. control group). The same approach will be used for the secondary outcomes (FACT-IT, HADS, BHS, DT, FACT-G, and ZB). Qualitative Analyses. Interviews will be digitally recorded with consent and analyzed thematically using a matrix. Each thematic matrix will contain data from the interviews pertaining to the theme in question, alongside participant information (demographics, changes in scores). The qualitative analysis will help explain the feasibility/acceptability. The team will implement minor refinements to enhance the relevance of the CASA intervention for the target population and context.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Puerto Rico
  • PR
    • Ponce, PR, Puerto Rico, 00717
      • Ponce Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Cancer patients must be stage III and IV solid tumor patients who report distress >4 on the Distress Thermometer
• Caregivers. Identified caregivers by distressed patients.

Exclusion Criteria:

• diagnosed with a major disabling medical or psychiatric condition
• unable to understand the consent procedure, or (3) too ill to participate, all as reported by the participant and/or determined by the investigator's judgment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual Care; Usual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions.	Behavioral: Placebo; Usual care will be provided to participants in the control group. The usual care consists of symptom management once a week and 5 sessions.
Experimental: CASA; The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be delivered to patients and caregivers. The sessions follow a protocol and will be held weekly or bi-weekly for a total of 5 sessions.	Behavioral: Caregivers-patients support intervention for advanced cancer (CASA); The Caregivers-Patients Support Intervention for Advanced Cancer (CASA) will be delivered to patients and caregivers. The sessions follow a protocol and will be held weekly or bi-weekly for a total of 5 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp)	The Functional Assessment of Chronic Illness Therapy-spiritual well-being (FACIT-Sp) is a 12-item measure of spiritual well-being designed for individuals with cancer and other chronic illnesses. Item development was informed by input from cancer patients, psychotherapists, and religious/spiritual experts. The measure will be administered at baseline (one to two weeks prior to the intervention) and post-intervention (one to two weeks following completion of the intervention). Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12) range from 0 to 48, with higher scores indicating greater spiritual well-being.	5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9)	The Patient Health Questionnaire-9 (PHQ-9) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention). The Patient Health Questionnaire-9 total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.	5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)
Generalized Anxiety Disorder-7 (GAD-7)	The Generalized Anxiety Disorder 7-item (GAD-7) is an easy to perform initial screening tool for generalized anxiety disorder. The measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention). The Generalized Anxiety Disorder 7-item scale total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.	5 minutes; the measure will be administered pre and post intervention (one to two weeks before the intervention and one to two weeks after the intervention)

Collaborators and Investigators

• Sponsor: Ponce Medical School Foundation, Inc.
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): July 30, 2027

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2411224820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No